Vigabatrin Patent Expiration

Vigabatrin was first introduced by Lundbeck Pharmaceuticals Llc in its drug Sabril on Aug 21, 2009. Another drug containing Vigabatrin is Vigafyde. 23 different companies have introduced drugs containing Vigabatrin.


Vigabatrin Patents

Given below is the list of patents protecting Vigabatrin, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Vigafyde US12576054 Vigabatrin Liquid Pharmaceutical Composition Jun 08, 2043 Pyros Pharms
Vigafyde US12290499 Vigabatrin liquid pharmaceutical composition Oct 17, 2042 Pyros Pharms
Vigafyde US12016857 Stable liquid vigabatrin pharmaceutical composition for oral dosage Aug 16, 2039 Pyros Pharms



Vigabatrin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Vigabatrin:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies Heather Olson NA RECRUITING
(Jul 1, 2026)
PHASE1
Treatment of Refractory Infantile Spasms With Fenfluramine Children's Hospital of Orange County NA RECRUITING
(Apr 1, 2026)
PHASE2


Vigabatrin Generic API Manufacturers

Several generic applications have been filed for Vigabatrin. The first generic version for Vigabatrin was by Ph Health Ltd and was approved on Apr 27, 2017. And the latest generic version is by Upsher Smith Laboratories Llc and was approved on Jun 29, 2023.

Given below is the list of companies who have filed for Vigabatrin generic, along with the locations of their manufacturing plants worldwide.